Boston-situated clinical-stage biotherapeutics company PureTech’s Phase IIb trial of deupirfenidone met all primary and secondary endpoints, slowing lung degeneration in patients with idiopathic pulmonary fibrosis (IPF).
The dose-ranging trial evaluated deupirfenidone (LYT-100) over a 26-day period, finding that the high dose was able to slow a decline in lung function, with the company hoping to establish the therapy as a new standard of care (SOC) for the condition.
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Patients in the randomised, double-blind trial (NCT05321420) were selected to receive deupirfenidone 550mg, deupirfenidone 825mg, or pirfenidone at the current US Food and Drug Administration (FDA) approved dose. Two doses of deupirfenidone were chosen based on Phase I data from a previous PureTech trial, which showed that a 550 mg TID dose of deupirfenidone provided approximately equivalent drug exposure to pirfenidone.
The trial’s primary endpoint found that deupirfenidone was superior to placebo in slowing the rate of lung function decline as measured by forced vital capacity (FVC) at 26 weeks. The trial also achieved its key secondary endpoint, finding that deupirfenidone was superior to placebo in slowing the rate of lung function decline in people with IPF.
Toby Mahe, the lead investigator in the trial, said: “The ELEVATE IPF trial broke new ground in Phase II trial design in IPF; this was the first time that a new therapy had been evaluated alongside one of the two existing SOC treatments.
“Deupirfenidone 825mg reduced lung function decline to near-physiologic levels over 26 weeks and had an effect size, compared with placebo, that was approximately 50% greater than that seen with pirfenidone. Deupirfenidone has the potential to offer patients a highly effective and tolerable treatment option. These are extremely exciting results from a Phase IIb trial, and I am very enthusiastic about the continued development of deupirfenidone.”
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By GlobalDataBharatt Chowrira, CEO of PureTech, said: “These data are remarkable, particularly for a monotherapy, and – if supported by a Phase III trial – would represent a step change in treating IPF.”
Elsewhere in the treatment of IPF, Trevi Therapeutics has announced that its Phase IIb CORAL trial of Haduvio. Meanwhile, Endeavor BioMedicines has dosed the first subject in the randomised Phase IIb WHISTLE-PF trial in Australia.
